No applications yet to hold COVID-19 vaccine trials in PH, says FDA

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Metro Manila (CNN Philippines, August 21) — While Philippine officials are eagerly awaiting the arrival of a COVID-19 vaccine, an official from the Food and Drug Administration (FDA) revealed that it has not yet received an application to hold a clinical trial in the country.

Jesusa Joyce Cirunay, head of FDA's Center for Drug Regulation and Research, said a vaccine manufacturer interested to hold the Phase 3 of the clinical trial in the Philippines has to submit an application and register for an import license before it can proceed.

"Wala pa kaming na-receive na clinical trial application... They cannot just have a clinical trial, they have to pass FDA," Cirunay said in an online forum.

The completion of the Phase 3 is required before the FDA reviews it for mass rollout.

Cirunay said it will take less than the regular 45-day process for the application to receive a go-signal from the FDA as long as the documents are complete.

Once a clinical trial is approved to be carried out in the Philippines, a member of the government's vaccine expert panel will identify the participants that will be first in line to receive the first dose of the vaccine through the research.

READ: Approval of Russia-made COVID-19 vaccine ‘good news,’ but local use depends on laws, clinical trials — Palace

Dr. Maria Liza Antoinette Gonzales of the University of the Philippines-Philippine General Hospital said those "at risk" — healthcare workers, frontliners, and those exposed to COVID-19 patients — will be prioritized.

If an application is submitted by September, she said the earliest a clinical trial will be completed is March 2021. Officials earlier said around 1,000 healthy Filipinos will be allowed to join the medical research.

Vaccine clinical trialist Dr. Josie Carlos said the timeline for the rollout of a regular vaccine normally takes 10 to 15 years, but in times of a global health crisis, it can be sped up to be completed in two years as long as the safety and efficacy can be assured.

"If we are in a pandemic, this may be fast tracked but following of course the scientific investigation and all the necessary regulations," she said.